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Vascular-Targeted Photodynamic Therapy Using WST11 in Patients With Localized Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

Vascular-Targeted Photodynamic Therapy Using WST11 in Patients With Localized Prostate Cancer

This trial is designed as a multicentre, phase II, open-labeled, multi-arm, single
intravenous (IV) dose study. The patient is to receive general anesthesia. WST11-mediated
VTP will consist of the combination of a single IV administration of WST11 at doses of 4 or
6 mg/kg using 753nm laser light at a fixed power (150 mW/cm or 200 mW/cm or 250 mW/cm ) and
light energy (200 J/cm or 300J/cm) delivered through transperineal interstitial optical
fibers. The fibers are introduced into transparent needles that are positioned in the
prostate under ultra sound guidance. The tumour location is established using transrectal
biopsy and MR imaging. The number of fibers and the total light energy will be adapted to
each patient based on a treatment planning proposed by treatment planning group.

Inclusion Criteria:

- Men over 18 years of age;

- Diagnosed with prostate cancer and eligible for active surveillance;

- No prior treatment for prostate cancer;

- Prostate Cancer Stage up to cT2b - N0/Nx - M0/Mx (rT2c and pT2c are acceptable)

- Gleason score ≤ 3+3 For patients characterized with prostate mapping (transperineal
template guided biopsy at 5mm intervals) a secondary pattern 4 is acceptable provided
that it is not present in more than 3 cores from each side of the prostate and is no
more than 3 mm cancer core length.

- PSA < 10 ng/mL;

- Signed Informed Consent Form.

Exclusion Criteria:

- Any condition or history of illness or surgery that, in the opinion of the
investigator and/or the Sponsor, might confound the results of the study or pose
additional risks to the patient.

- All patients whose current pre-operative cardiac evaluation does not show their
fitness for a procedure requiring general anesthesia;

- Patients with a prior history of viral or alcoholic hepatitis, and other patients
felt to be at risk for hepatotoxicity including concomitant use of potentially
hepatotoxic medications or dietary supplements;

- Patients with a history of inflammatory bowel disease or other factors which may
increase the risk of fistula formation;

- Men who have received any hormonal manipulation (excluding 5-alpha reductase
inhibitors) or androgen supplements within the previous 6 months;

- Men previously treated by radiation therapy (external therapy or brachytherapy) or
chemotherapy or any therapy for prostate cancer;

- Men who have received or are receiving chemotherapy for prostate carcinoma or other
significant cancer;

- Men who have undergone previous TURP (trans-urethral resection of the prostate);

- Men who are currently receiving any medications having potential photosensitizing
effects (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic
agents, thiazide diuretics and griseofulvin).

- Men who are receiving anticoagulant drugs (e.g.: coumadin, warfarin).

- Patient who stopped long term treatment of acetylsalicylic acid (aspirin) or other
anti platelets agents less than 15 days before the procedure;

- Patient suspected of Disseminated Intravascular Coagulation (DIC) as defined by the
presence of three out of the five following criteria: platelets ULN, aPTT
>ULN, fibrinogenULN

- History of non compliance with medical therapy and medical recommendations or an
unwillingness or inability to complete patient self-administered questionnaires;

- Participation in a clinical study or receipt of an investigational treatment within
the past 3 months;

- A history of porphyria;

- A history of sun hypersensitivity or photosensitive dermatitis;

- Renal disorders (blood creatinine > 1.5 x ULN) or known post mictional residue >

- Hepatic disorders (transaminases > ULN, bilirubin > ULN,). In case of slight
abnormalities, another exam should be performed. If the results are within normal
ranges, then the patient can be included;

- Hematological disorders (white cells < 2500/mm3, neutrophils < 1500/mm3, platelets <
140.000/mm3, Hb < 8 g/dL);

- Patient with contra-indication to MRI (such as pace maker, metal prosthesis, etc.).

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Negative biopsy in the treated lobes

Outcome Time Frame:

Month 6

Safety Issue:


Principal Investigator

Mark Emberton, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

University College London Hospital (UCLH)


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CLIN902 PCM203



Start Date:

September 2009

Completion Date:

August 2012

Related Keywords:

  • Prostate Cancer
  • Prostatic Disease
  • Genital neoplasm, male
  • Urogenital neoplasm
  • Genital disease,male
  • Male urogenital disease
  • Neoplasms
  • Neoplasm by site
  • Prostatic neoplasm
  • Carcinoma
  • Prostatic Neoplasms